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K Number
K023689
Device Name
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
2003-01-17

(77 days)

Product Code
DXH
Regulation Number
870.2920
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Patients wishing to acquire, display and transmit their vital signs to a medical professional via Web-based Call Center for analysis and obtain response

Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain specific information about:

  • Acceptance criteria and device performance in a table format.
  • Details of a study conducted to prove the device meets acceptance criteria (like sample sizes, data provenance, expert qualifications, or adjudication methods).
  • Information about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
  • Type of ground truth used or training set details.

The letter primarily confirms that the device, CG-500 PMP4 Personal Medical Phone System, is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and directs the applicant to comply with various regulations, but it does not describe the technical performance evaluation of the device.

Therefore,Based on the provided document, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, and training set information is not available. The document is a 510(k) clearance letter, which affirms that the device is substantially equivalent to a predicate device, but it does not contain the detailed study results or design elements that would describe how that substantial equivalence was demonstrated in terms of performance metrics.

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).